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yang.chen4@thermofisher.com
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13386161207
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xinjinqiao
Thermo Fisher Scientific (China) Co., Ltd
Innovate and iterate Chromeleon, handle compliance supervision with ease and ease
Date: 2025-11-07Read: 2
Chromeleon 7.4
With the continuous upgrading of regulatory and supervisory attention to pharmaceutical laboratory data, data integrity has become an increasingly important focus of audit attention, and the compliance system urgently needs technical empowerment. Thermo Fisher Scientific closely follows the new changes in pharmaceutical industry regulations and actively adapts to market demands. Thermo Scientific will be presented at the Annual Meeting of the American Society for Mass Spectrometry (ASMS) in 2025 ™ Chromeleon ™ Version 7.4 has added multiple compliance tools, which not only improve the accuracy and efficiency of data processing, but also meet compliance requirements, ensuring that enterprises can quickly adapt to constantly changing regulatory requirements and maintain a competitive advantage.
ruleset
In versions prior to Chromeleon 7.3, the scope of permission to modify processing methods was relatively broad. The concept of rule sets was introduced in Chromeleon 7.3.2 to achieve fine-grained control over data processing method permissions. Users can modify necessary parameters (such as retention time window, reference concentration), and can also limit the modification of non adjustable parameters (such as prohibiting the modification of integral parameters) according to SOP.
Now, the Chromeleon 7.4 software extends this refined management to the sequence and sample management modules. Through the rule set, system administrators can define the sequence and sample fields that each role can modify, such as allowing users to modify the sample type, dilution factor, annotation, or sequence annotation, but cannot modify certain fields that require caution, such as sample name, injection volume, and instrument assigned to the sequence. This refined management enables system administrators to handle compliance management more efficiently, reducing the pressure of data review before release.
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Enable/Disable Dynamic Data Processing
Dynamic data processing is a traditional advantage feature of Chromeleon, which ensures that changes made during data processing are reflected in real-time in the data and results, thereby saving the time required to create suitable processing methods. However, according to the new trend of regulatory development, some regulatory agencies have begun to require users to hide the processing results before saving and submitting the points parameters, in order to avoid human factors affecting the final results and achieve a more transparent and auditable data processing process.
In Chromeleon 7.4, system administrators can set whether to enable dynamic data processing as needed. If you want to disable dynamic calculations based on real-time preview, you can disable this feature in the policy; But for laboratories that pursue efficiency, we still recommend enabling this feature. This also fully reflects the efficient and compliant characteristics of Chromeleon software, which can meet the personalized needs of different customers.
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Delete Idle Sample Injection Permission
Idle injection refers to samples that have not yet been injected and do not have raw data. Deleting idle samples does not have any impact on data integrity. It should be noted that in the data audit trail, the action of deleting idle samples will be marked as "not containing raw data" to distinguish it from deleting samples that have already been injected. As regulatory granularity becomes finer, many auditors and laboratory managers need to be able to restrict the deletion of uninjected samples, even if they do not contain raw data.
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In the new version, the "Delete Idle Samples" permission has been added to control the deletion of non injected samples and ensure record accuracy.
As a leading chromatographic data system in the industry, Chromeleon 7 is committed to providing comprehensive data integrity and compliance solutions for laboratories. The system is based on simplicity, intelligence, and compliance, continuously optimizing and upgrading functional modules to ensure that users always stay ahead of compliance requirements. With the comprehensive upgrade of compliance features, Chromeleon 7.4 can effectively eliminate risks caused by regulatory updates and provide solid guarantees for the integrity of scientific data. Even in the face of increasingly strict compliance supervision, it can be handled with ease and ease.